Residual effects of zopiclone 7.5 mg on cognition and driving performance in insomnia patients chronically using hypnotics - Insomniacs driving after use of zopiclone 7.5 mg

Phase 1

• Conditions: Primary insomnia; MedDRA version: 9.1Level: LLTClassification code 10036701Term: Primary insomnia

• Registration Number: EUCTR2008-002003-75-NL
• Lead Sponsor: Maastricht University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-23
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Aged 55 years or older
2. Possession of a valid driving license for 3 years or more (for >70 years: Possession of Declaration of Appropriateness’ (in Dutch: Verklaring van Geschiktheid))
3. Average driving experience of at least 3000 km per year over the last three years
4. Mentally and physically fit to drive
5. Good health, in the opinion of the medical supervisor, on the basis of a pre-study physical examination, medical history, vital signs, electrocardiogram, and the results of blood biochemistry, haematology, and serology tests, and urinalysis
6. For patients: complaints of insomnia

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. History of drug or alcohol abuse
2. Chronic use of medication that affects driving performance (such as anti-epileptics, anti-psychotics, anti-depressants, anti-parkinsonian medication), except hypnotics
3. Drinking more than 6 cups of coffee per day
4. Drinking more than 21 glasses of alcohol per week
5. Smoking more than 10 cigarettes per day
6. BMI over 30 kg/m²
7. For patients: Sleep-Related Breathing Disorders; Circadian Rhythm Sleep Disorders; Sleep-Related Movement Disorders

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine whether the residual effects of zopiclone 7.5 mg on driving performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Secondary Objective: To determine whether the residual effects of zopiclone 7.5 mg on cognitive and psychomotor performance in patients complaining of insomnia and who chronically use hypnotics differ from the effects in insomnia patients who do not regularly use hypnotics and from matched healthy controls.;Primary end point(s): The main study parameter is Standard Deviation of Lateral Position (SDLP in cm) in the highway driving test.